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临床试验/NCT06166446
NCT06166446已完成不适用

Comparison of Denture Base Adaptation and Per-implant Tissue Health Between CAD and CAM Implant Retained Complete Overdenture

Mansoura University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Modified Plaque Index

研究概览

简要总结

Background: Complete overdenture manufacturing has been greatly developed using computer-aided designing and computer-aided manufacturing (CAD-CAM) technology.

Material and method: 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue and denture adaptation were evaluated using clinical parameters

详细描述

Background: In recent years, complete overdenture manufacturing has been greatly developed using computer-aided designing and computer-aided manufacturing (CAD-CAM) technology. This clinical study compared the soft tissue health between CAD/CAM-milled and 3D-printed implants that retained complete overdentures.

Material and method: 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue was evaluated using clinical parameters including the gingival index, plaque index, bleeding index, and probing depth at the time of mandibular complete overdenture insertion (T0), six months (T6), and twelve months (T12) of denture use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
58 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •poor denture adaptation co-operative patients

排除标准

  • •metabolic diseases uncontrolled diabetes osteoporosis and hyperparathyroidism.

研究组 & 干预措施

a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture

Active Comparator

patients received lower denture fabricated by milling technique

干预措施: subtractive technique (Device)

3rd printed mandibular overdenture and a maxillary acrylic conventional complete denture

Active Comparator

The denture base was fabricated by adding the material layer by layer

干预措施: additive technique (Device)

结局指标

主要结局

Modified Plaque Index

时间窗: 12 months

a calibrated pressure sensitive plastic periodontal probe, the distance between marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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